text: Background During a disease outbreak, including the Zika virus, HHS is the lead federal agency for public health and medical response, and it leverages national public health and medical resources to prepare for and respond to the outbreak. Zika Virus Transmission and Prevention The Zika virus is primarily transmitted to humans by infected mosquitoes, but can also be transmitted from mother to child during pregnancy or around the time of birth, or from person-to-person through sexual contact or blood transfusion. According to CDC, once an individual has been infected with the Zika virus, they are likely to be protected from future infections. The Aedes aegypti mosquitoes are reportedly the primary mosquito spreading the Zika virus, while the Aedes albopictus mosquitoes, which share many of the same traits as Aedes aegypti, also have the ability to spread the virus. Local transmission of the virus has occurred in American Samoa, Florida, Puerto Rico, Texas, and the U.S. Virgin Islands. Travel-associated cases of Zika virus infection have been reported in every state, with the largest numbers of cases reported in California, Florida, New York, and Texas. There is no vaccine to prevent the Zika virus, so CDC guidance recommends preventing the spread of the virus by protecting against mosquito bites by wearing protective clothing, using insect repellant, and staying in places with air conditioning and window and door screens to keep mosquitoes outside, among other actions. Mosquito control in the United States is implemented and overseen at the state and local levels by entities such as mosquito control districts and health agencies. Federal agencies support such control entities with funding and subject matter experts, and may regulate some control methods such as pesticides. Zika Funding Prior to September 2016 In April 2016, the Office of Management and Budget and the Secretary of Health and Human Services announced that they had identified $589 million—$510 million of it from existing Ebola virus disease resources within HHS, the Department of State, and the U.S. Agency for International Development—that could quickly be redirected and spent on immediate efforts to control and respond to the spread of the Zika virus. According to HHS, out of the $589 million, $374 million was redirected to domestic Zika virus control activities. HHS reports that almost all of this funding ($354 million) was distributed to three HHS agencies, as follows: CDC received $222 million for various activities including field staff, state response teams, Zika virus testing, tracking of pregnant women who were infected with the Zika virus, and grants for mosquito control and other Zika prevention activities; BARDA received $85 million for private sector development of Zika vaccines, treatments, and technologies to protect the blood supply, and other countermeasures; and NIH received $47 million for Zika medical countermeasure development, including clinical trials on the leading Zika vaccine candidate. Additionally, according to HHS officials, in August 2016, the Secretary of Health and Human Services notified Congress of the department’s intent to redirect an additional $81 million in unobligated HHS funds for Zika vaccine development activities. Of this amount, $34 million was drawn from accounts at NIH and $47 million was drawn from funds transferred from other HHS agencies and reprogrammed from within PHSSEF. From these redirected funds, $34 million (i.e., the amount drawn from other NIH accounts) was to be used by NIH to continue clinical trials on its lead Zika vaccine candidate. The remaining $47 million was to be used by BARDA for continued private sector Zika vaccine development. September 2016 Zika Supplemental Funding In September 2016, Congress appropriated $932 million to HHS and its agencies in the Zika Response and Preparedness Act. Of that amount, $394 million was appropriated directly to CDC and $152 million was appropriated directly to NIH. The remainder was appropriated to HHS’s PHSSEF, from which HHS allocated $245 million to BARDA within the Office of the Assistant Secretary for Preparedness and Response, $75 million to CMS, and $66 million to HRSA. (See fig. 1.) The Zika supplemental funding remained available for obligation until September 30, 2017, for the following purposes: CDC: to prevent, prepare for, and respond to the Zika virus, health conditions related to the virus, and other vector-borne diseases, domestically and internationally. NIH: for research on the virology, natural history, and pathogenesis of the Zika virus infection, and preclinical and clinical development of vaccines and other medical countermeasures for the Zika virus and other vector-borne diseases, domestically and internationally. PHSSEF: for various activities, including to prevent, prepare for, and respond to the Zika virus, health conditions related to the virus and other vector-borne diseases, domestically and internationally; and to develop necessary countermeasures and vaccines, including the development and purchase of vaccines, therapeutics, diagnostics, necessary medical supplies, and administrative activities. BARDA: HHS allocated funding to BARDA to support further development of Zika vaccine candidates, diagnostics, and pathogen reduction technologies initiated in fiscal year 2016 to advance these projects toward licensure or approval by the Food and Drug Administration. CMS: HHS allocated funding to CMS for expenses to support states, territories, tribes, or tribal organizations with active or local transmission cases of the Zika virus, as confirmed by CDC. The funding was allocated to reimburse the costs of health care for health conditions related to the Zika virus, other than costs that are covered by private health insurance, of which not less than $60 million were for territories with the highest rates of Zika virus transmission. HRSA: HHS allocated $20 million for projects of regional and national significance in Puerto Rico and other U.S. territories, $40 million to expand the delivery of primary health services in Puerto Rico and the other territories, and $6 million to be used to assign National Health Service Corps members to Puerto Rico and the other territories to provide primary health services in areas affected by the Zika virus or other vector-borne diseases through the National Health Service Corps Loan Repayment Program. Agencies have until September 30, 2022, to disburse the Zika supplemental funding appropriated by the Zika Response and Preparedness Act. HHS Agencies Have Obligated Nearly All of the Zika Supplemental Funding; Disbursements Are Ongoing Agencies Obligated Nearly All of Their Zika Supplemental Funding as of September 30, 2017, Primarily Through Cooperative Agreements, Grants, and Contracts We found that as of September 30, 2017—the end of the Zika supplemental appropriation’s period of availability—nearly all Zika supplemental funding had been obligated, primarily through cooperative agreements, grants, and contracts. BARDA obligated 100 percent of its Zika supplemental funding, while CDC, CMS, HRSA, and NIH obligated over 99 percent of their funding. (See table 1.) Three of the five agencies had obligated over half of their Zika supplemental funding by January 31, 2017, 4 months after enactment of the appropriation. For example, according to CDC officials, using cooperative agreements with application processes familiar to the awardees helped enable the agency to obligate its funding soon after receiving the appropriation. Some agencies began obligating later in the one-year obligation time frame based on their approach to obligating the Zika supplemental funding. For example, CMS withheld a portion of its supplemental funds in the event additional awardees became eligible for funding within the obligation time frame—eligibility included having active or local transmission of the Zika virus. Agency officials told us that they used cooperative agreements, grants, and contracts to award Zika supplemental funding to existing and new awardees. The agencies also used other mechanisms to obligate the Zika supplemental funding, such as interagency agreements, intramural research awards, and funding used within the agency for travel and other expenses. According to officials, agencies used these mechanisms to award Zika supplemental funding in the following ways. BARDA executed new contracts and modified existing contracts through the agency’s typical contracting process, officials said, for research in the areas of Zika clinical diagnostics and vaccine development. BARDA did not use any Zika supplemental funding to support internal administrative or personnel costs. (See app. I for the contracts BARDA awarded with its Zika supplemental funding.) CDC generally obligated Zika supplemental funding to current awardees through existing cooperative agreements, according to agency officials. (See app. II through VII for the cooperative agreements CDC used to award Zika supplemental funding to existing awardees.) CDC also awarded funding through contracts and interagency agreements, and obligated about $24 million for internal CDC expenses, such as salaries and benefits, travel, supplies, and equipment. (See app. VIII for the contracts and interagency agreements CDC awarded with its Zika supplemental funding.) CMS created a new program—the Zika Health Care Services Program—to award its Zika supplemental funding through cooperative agreements, according to agency officials. The purpose of the 3-year program is to support prevention activities and treatment services for women (including pregnant women), children, and men adversely or potentially affected by the Zika virus. CMS awarded funding through the Zika Health Care Services Program to those states, territories, tribes, or tribal organizations with active or local transmission of the Zika virus, as confirmed by CDC. CMS awarded funding to the health departments in American Samoa, Florida, Puerto Rico, and the U.S. Virgin Islands in January 2017. In June 2017, CMS awarded funding to the health department in Texas, the only new state or territory with local transmission of the Zika virus. In both CMS award rounds, only states and territories received awards, because they were the only areas with active or local transmission of the Zika virus. CMS retained about $3.6 million of the Zika supplemental funding to use for administrative support services, as well as for travel for monitoring and oversight. (See app. IX for the awards CMS made with its Zika supplemental funding.) HRSA generally obligated Zika supplemental funding through grants to existing awardees, according to agency officials. HRSA did not retain any Zika supplemental funding for internal activities. (See app. X for the grants HRSA awarded.) NIH used grants and contracts to award its Zika supplemental funding to new and existing awardees. NIH also used about $95 million of the Zika supplemental funding for internal activities—studies conducted by NIH researchers. According to NIH officials, the somewhat unique aspects of the Zika virus as an arbovirus infectious disease led NIH to focus on vaccines as a priority, along with development of diagnostics, therapeutics, vector control, and surveillance. (See app. XI for NIH’s Zika supplemental awards.) For more information on the funding provided by CDC, CMS, and HRSA—the only agencies that provided funding for states and territories—and the number of reported Zika cases by state or territory, see an interactive graphic at https://www.gao.gov/products/GAO-18-389. Officials from all five agencies cited coordination initiatives through regular interagency or organizational teleconferences and participation in working groups. According to CMS officials, during the Zika virus response, CDC, CMS, HRSA, and other federal partners held interagency Zika coordination calls to discuss ongoing developments related to the Zika virus. Additionally, because CMS and HRSA were both awarding funding for perinatal health care services, officials said they collaborated to ensure that activities available through the CMS grants complemented the activities available through HRSA’s Special Projects of Regional and National Significance. In addition, HRSA officials reported conducting joint site visits with CDC and CMS, as well as streamlining reporting requirements to reduce grantee reporting burden. Furthermore, BARDA officials said that they awarded and administered a contract for CDC on the development of a vector control product. CDC provided the funding and topical subject matter expertise for the award, and BARDA provided management services for the contract, because of BARDA’s experience with these types of contracts. BARDA and NIH officials also reported collaborating on vaccine development. BARDA officials explained that while the vaccine development process requires that different agencies support multiple vaccine development candidates, the two agencies coordinated to avoid redundancy. Agencies Had Disbursed About 21 Percent of the Zika Supplemental Funding as of December 31, 2017 We found that as of December 31, 2017, the HHS agencies had disbursed about 21 percent (approximately $195.5 million of $932 million) of the Zika supplemental funding. According to agency officials and selected awardees we spoke with, various factors can affect the disbursement of funding after obligation. These factors include time to draw down funding from the federal agencies, allowing for program implementation and a planning period, and awardees’ internal administrative processes and unique characteristics, as described below. Drawdown procedures. CDC officials said that awardees draw down federal funding on their individual schedules based upon how they manage their federal funding. Some awardees draw down on a daily basis, as needed, while others draw down on a biweekly or monthly basis. Additionally, drawdowns for personnel costs coincide with payroll schedules, which could be biweekly or monthly. For example, in the case of monthly payroll, two awardees told us that the federal funding for a particular month’s expenses would be drawn down the following month. Furthermore, selected awardees we spoke with said that they draw down federal funding after they have incurred an expense, such as when they receive an invoice. For example, Los Angeles County officials reported that in order to draw down the funds for the organization that is responsible for servicing their vector control activities, they have to first receive an invoice from the organization, which the county pays with its own funds. Only then can the county draw down the federal funding. This process usually results in at least a 3-month period between receiving the invoice and drawing down the federal funding, officials said. Program implementation and planning period. According to CMS officials, the agency awarded funding to health departments in American Samoa, Florida, Puerto Rico, Texas, and the U.S. Virgin Islands from the Zika Health Care Services Program, which was a new collaboration between CMS and these specific awardees. The officials said that the steps awardees needed to take to stand-up new programs—such as budget review and approval processes, selection of key personnel to administer the grant, grant activities related to contracting, and hiring and procurement—can delay start-up and implementation of the grant programs. Additionally, CMS gave awardees in the Zika Health Care Services Program a 3-month planning period after they received their notices of award to amend their activities. For example, Texas officials reported that they used the 3-month planning period to work on executing contracts with the local health departments in three counties bordering Mexico. Texas officials explained that collaborating with the local health departments entailed determining the greatest potential benefit of the use of the funds, because the award itself was not enough to cover all of the costs of direct health care services associated with the Zika virus. Awardees’ processes and characteristics. Local administrative processes for spending federal supplemental funds can result in varied disbursement time frames. For example, California received Zika supplemental funding for an award that required an amendment to an administrative contract, which state officials said takes about 7 to 8 months for internal state approval. Additionally, certain awardees’ characteristics affect disbursements. For example, Houston officials said the city was eligible for and was directly awarded a CDC cooperative agreement, but because it does not conduct vector control activities itself, the city had to negotiate a contract with the surrounding county to conduct these activities, adding additional time before it could begin disbursements. Officials also noted that awardees’ personnel hiring issues can affect disbursement time frames. For example, CMS officials said that some territories experienced delays in carrying out activities due to provider shortages, particularly among specialists needed to care for children with developmental delays and birth defects caused by the Zika virus. CMS officials noted that island jurisdictions, such as the U.S. territories, can find hiring more difficult due to a shortage of health care professionals available within the territory, thus requiring individuals to be recruited from outside the territory, which adds time to the process and raises costs. In addition, Florida officials in Miami-Dade County reported that the necessary staff surge during the Zika response was challenging to fill, noting that it was particularly difficult to find phlebotomists and nurses, because they were in high demand. Standard vaccine development processes also influenced the rate of disbursement. Due to the long duration of the vaccine development process, BARDA officials said, disbursements to certain awardees have occurred at varying intervals. For example, some contract invoices are received on a monthly basis, or twice a month if the company is a small business. The invoices are then reviewed and if deemed acceptable, they are processed for payment. The 2017 hurricane season may have affected certain awardees’ use of their Zika supplemental funding, which prompted agencies to respond by approving various types of short-term relief for administrative, financial management, and audit requirements for awardees affected by the hurricanes. Three agencies—CDC, CMS, and HRSA—awarded Zika supplemental funding to areas affected by hurricanes Harvey, Irma, and Maria in 2017: Florida, Puerto Rico, Texas, and the U.S. Virgin Islands. CDC officials told us, for example, that because of the hurricanes they granted extensions at the request of the awardees for submitting financial and progress reports, and continuation of activities. Similarly, CMS offered hurricane-affected awardees of the Zika Health Care Services Program the option to extend the deadline for deliverables, if necessary. CMS officials told us that grant activities had been affected by the hurricanes, and all grantees had communicated the intent to fully resume activities as soon as they are able to do so. Due to the 3-year project period for grantees, CMS officials said that the affected entities can still accomplish programmatic responsibilities, even if there is a temporary halt in project activities. Furthermore, HRSA officials said that they provided Puerto Rico and the U.S. Virgin Islands with extensions on required program, financial, and audit reports. Selected Awardees Undertook Multiple Activities with Zika Supplemental Funding, and Had Varying Experiences Applying for and Managing Funds Selected Awardees Used Zika Supplemental Funding for Activities Including Surveillance, Vector Control, Laboratory Capacity, and Health Care Services Selected awardees we spoke with used Zika supplemental funding for a variety of activities. Collectively, the activities included four primary types: medical surveillance, vector control, laboratory capacity building, and providing health care services, as described below. Medical surveillance activities include identifying and reporting Zika virus disease cases to CDC, as well as reporting Zika virus infections in pregnant women and infants to the U.S. Zika Pregnancy Registry. Vector control activities include detecting and monitoring Aedes aegypti and Aedes albopictus mosquito distribution and mosquito control, and monitoring of insecticide resistance and management. Laboratory capacity building activities include developing laboratory capacity to perform Zika virus testing. Health care service activities for those selected awardees that received funding from CMS (Florida and Texas) included increasing access to contraceptive services for men and women; increasing access to and reducing barriers to diagnostic testing, screening, and counseling for pregnant women and newborns; and increasing access to appropriate specialized health care services for pregnant women, children born to mothers with maternal Zika virus infection, and their families. Table 2 provides examples of the types of activities funded by the selected awardees we interviewed. This table does not include a comprehensive list of all of the awardees’ Zika activities—see appendixes II through VI, and appendix IX for more information on the Zika supplemental funding CDC and CMS awarded to states, territories, and local jurisdictions. Of the awardees we spoke with, Florida and Texas were the only states that had experienced local mosquito-borne transmission of the Zika virus. Other selected awardees—which included Arizona, Los Angeles County, and Louisiana—were primarily responding to travel-related cases of Zika virus disease. The following are additional examples of activities funded using Zika supplemental funding. For more information on the types of activities authorized under each award, see appendixes II-VI and IX. Florida. Florida, which has a centralized health department with county- based offices, used Zika supplemental funding for laboratory capacity and vector control activities, among other activities. According to state officials, funding for state-run laboratories was used for purchasing materials, such as those used for testing urine for the Zika virus, and funding staff located in counties to assist with handling Zika samples and testing, data entry, and result reporting to surveillance networks. Additionally, Florida used Zika supplemental funding for local vector control activities. For example, Miami-Dade County officials said that they purchased mosquito traps and removed mosquito breeding grounds, including plants, tires, and other objects that can hold standing water. (See fig. 2 for examples of the mosquito control activities in Miami-Dade County.) Through CMS’s Zika Health Care Services Program, Florida received funding for, among other things, two part-time advanced registered nurse practitioners to provide consultation and technical assistance in family planning clinics, and assist in the prescribing and management of various birth control methods. Florida also funded a health educator for Zika prevention and response duties, which included assisting local health care organizations in the development of educational programming to ensure that health care services are provided in accordance with CDC guidelines. The health educator’s duties also included ensuring that pregnant women with the Zika virus and infants with congenital Zika infection are referred to proper care and other available programs and resources. Texas. Texas officials said that the state used a CDC award to rapidly identify cases and conduct data analysis of Zika-related birth defects, to enhance surveillance of Zika virus-related birth defects by improving the Texas Birth Defects Registry database, and to facilitate remote access to electronic records. Texas also disseminated prevention materials and interviewed mothers of children with Zika-related birth defects about their experience in dealing with the health system in order to help identify developmental outcomes of the children. Texas intends to use its CMS Zika Health Care Services Program funding—awarded on June 30, 2017—to increase clients’ access to contraceptives; for care management, including counseling on Zika virus testing for pregnant women and their families; and for counseling to refer clients for services and support. State officials provided the following information on some of the activities intended for the program. 1. Increasing clients’ access to contraceptives: Community health workers and case management staff will assist clinic providers with informing women and their partners about contraceptive availability and about the potential Zika virus risks during pregnancy. They will also work with the women to determine what messages work best with their partners regarding contraceptives. 2. Care management that includes pre- and post-test counseling on Zika virus testing for pregnant women and their families: Officials said that this activity is important because the CDC testing algorithm is complex, the results from various tests can be confusing, and there can be false positives from the tests. Generally, doctors do not have the time to go through the complexities of these issues with clients, such as how to understand the laboratory tests and results. 3. Counseling to refer clients for services and supports: This can include counseling about various types of resources to support clients pre- delivery, after delivery, and during the infant’s first year of life. Arizona. According to state officials, Zika supplemental funding was used to create an action plan with counties, and increase the state’s ability to raise public awareness about the threat of the Zika virus, its transmission routes, and prevention measures. Officials stated that Arizona’s border with Mexico makes communicating about Zika more complex, because individuals frequently cross the border for a variety of reasons including work, school, and to visit family, and do not necessarily consider themselves to be travelers. Additionally, the state used funding to increase the amount of personal protective equipment for the vector surveillance staff, and set up vector control contracts that could be accessed if the Zika virus spread locally, and in the event that vector control could not be handled at the local level. However, this contracting mechanism was not used, because there was no local transmission of the Zika virus in Arizona. According to state officials, Arizona plans to ask for an extension to use the funding in the next mosquito season. The state health department also sponsored training on mosquito identification. Los Angeles County. County officials said that some funding was used to support personnel involved with Zika surveillance, testing, and case management. This included the detection of cases—individuals diagnosed with Zika infection—and also the dissemination of information to Los Angeles County’s Maternal and Child Health group, which follows pregnant women through delivery and then transfers the cases to the county’s Children’s Medical Services group. For example, according to officials, once a case is identified, information is shared with the relevant vector control district about the location of the case, and the vector control district can then conduct inspection and abatement activities to reduce the risk of a local outbreak. Los Angeles County officials found that this process takes about one week from finding out about a case to completion of inspection and abatement. This included 1 day to get information to the vector control district and 1 to 5 days for completing inspection and abatement. The funding was also used to provide funds to the vector control districts to augment Aedes mosquito detection efforts and support outreach activities, according to county officials. Louisiana. Louisiana officials said they used a CDC award, in part, to provide equipment and mileage reimbursement for nurses, who served as clinical liaisons between the birth defects surveillance program and hospitals and physicians statewide, to help enable rapid surveillance activities. Awardees also funded other activities, such as outreach campaigns. See figure 3 for examples of outreach funded with Zika supplemental funding. Selected Awardees Had Mixed Experiences Applying for and Managing the Zika Supplemental Funding While a majority of the 12 selected awardees we spoke with reported positive experiences with the process of applying for and managing the Zika supplemental funding, some awardees cited aspects of the process that were challenging. The awardees we spoke with received much of their supplemental funding from CDC and noted that the process went well: there was good communication with CDC officials; CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases cooperative agreement process to apply for Zika supplemental funds was more streamlined than the regular application process; and awardees said they were familiar with the mechanisms, which helped them navigate the process. Awardees we spoke to also cited some challenges to applying for and managing the Zika supplemental funding. These awardees noted that various time frames among multiple awards and restrictions on authorized activities under the awards added administrative burdens that officials had to deal with while responding to the outbreak. Florida officials said that the state received funding from different federal agencies, from different cooperative agreement awards, with different deadlines, and different rules on what the funding could be used for. For example, CDC distributed Zika supplemental funds to states and certain localities and territories through five cooperative agreements—some of which had multiple application rounds. Florida officials said that they had to track funding separately and identify the activities that could be funded under each award—administrative requirements that were burdensome during an emergency response. Figure 4 presents the period of time Florida had to use the Zika supplemental funding from multiple awards received from CDC. In addition, awardees we spoke with cited challenges with adjusting their plans when federal funding was more or less than anticipated. For example, CDC officials said that they provided average award amount ranges as guidance for awardees as part of the application process for one of CDC’s cooperative agreements. Los Angeles County officials said that they applied for an amount that was near the limit, and county officials said that they had to adjust the activities they planned to fund when they received less than what they applied for. Iowa officials said that without knowing exactly how much funding would be available it was difficult to know what to apply for and made staffing changes difficult. Iowa officials had to adjust their initial plan when they later received additional unexpected funding. In October 2017, CDC issued a new notice of funding opportunity that, according to agency officials, was intended to help minimize the administrative burden on these awardees (e.g., preparing applications and other paperwork) during significant public health emergencies by pre- approving public health departments in these jurisdictions to rapidly receive future awards. This new notice of funding opportunity will be used to establish a list of awardees, with existing emergency preparedness and response capacity, that would be pre-approved for funding by CDC when a public health threat occurs, including infectious disease threats. It requires that awardees have structures and plans in place to receive funding, as well as plans to respond to a public health threat. According to CDC officials, awards could potentially be provided within 2 weeks to pre-approved awardees after supplemental appropriations are enacted. According to CDC officials, as of February 2018, the agency had approved all 64 applicants for the notice of funding opportunity. This means that CDC will consider these approved applicants for future funding if an emergency occurs and funding becomes available. Agency and Third- Party Comments We provided a draft of this report to HHS for review and comment. HHS provided technical comments, which we incorporated as appropriate. We also provided relevant draft portions of this report to the Zika supplemental funding awardees we interviewed. Specifically, we provided the excerpts to officials in Alaska; Arizona; California; Colorado; Florida; Houston, Texas; Iowa; Kansas; Los Angeles County, California; Louisiana; Oklahoma; and Texas. All but one awardee responded. Awardees provided technical comments, which we incorporated as appropriate. We are sending copies of this report to the appropriate congressional committees, the Secretary of Health and Human Services, and to other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or crossem@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix XII. Appendix I: Biomedical Advanced Research and Development Authority’s Zika Supplemental Awards The Biomedical Advanced Research and Development Authority (BARDA), within the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, executed contracts to obligate its Zika supplemental funding for research in the areas of (1) vaccine development, (2) diagnostic development, and (3) pathogen reduction systems. Table 3 presents information for each award as it was provided to us by BARDA. Appendix II: Centers for Disease Control and Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) cooperative agreement. CDC awarded Zika supplemental funding for the ELC cooperative agreement for the following activities: Zika vector surveillance and control, Zika epidemiology and laboratory surveillance, and U.S. Zika Pregnancy Registry. The Zika supplemental funding awarded through the ELC cooperative agreement was to further support and strengthen activities to protect the public’s health, especially pregnant women, through epidemiologic surveillance and investigation, improving mosquito control and monitoring, and strengthening laboratory capacity. The funding will also support participation in the U.S. Zika Pregnancy Registry to monitor pregnant women with the Zika virus disease and their infants. For each award, we present information as it was provided to us by CDC, as well as the activities funded. Table 4 provides information on ELC Zika supplemental funding awarded to states and territories, and table 5 presents information on awards to local health departments. In addition to states and territories, six large city and county local health departments—Chicago, the District of Columbia, Houston, Los Angeles County, New York City, and Philadelphia—received ELC Zika supplemental awards. Appendix III: Centers for Disease Control and Prevention—Birth Defects Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Surveillance, Intervention, and Referral to Services Activities for Infants with Microcephaly or other Adverse Outcomes Linked with the Zika Virus (birth defects) cooperative agreement. The Zika supplemental funding awarded through the birth defects cooperative agreement was to provide additional resources to better establish, enhance, and maintain rapid population-based surveillance of microcephaly and other adverse outcomes (especially central nervous system defects) possibly linked to Zika virus infection during pregnancy using an active case-finding methodology; participation in centralized pooled clinical and surveillance data projects; ensuring affected infants and families are referred to services; and assessing health and developmental outcomes of these children. Table 6 presents information for each award as it was provided to us by CDC. Appendix IV: Centers for Disease Control and Prevention—Behavioral Risk Factor Surveillance System Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Behavioral Risk Factor Surveillance System (BRFSS) cooperative agreement. The Zika supplemental funding awarded through the BRFSS cooperative agreement was to conduct a rapid population-based assessment of women and couples using or in need of contraceptives in order to provide comprehensive contraceptive services related to Zika virus exposure. Table 7 presents information for each award as it was provided to us by CDC. Appendix V: Centers for Disease Control and Prevention—Pregnancy Risk Assessment Monitoring System Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Pregnancy Risk Assessment Monitoring System (PRAMS) cooperative agreement. The Zika supplemental funding awarded through the PRAMS cooperative agreement was to assess maternal behaviors and experiences related to Zika virus exposure among recently pregnant women who deliver a live- born infant in the United States. Table 8 presents information for each award as it was provided to us by CDC. Appendix VI: Centers for Disease Control and Prevention—Public Health Preparedness and Response Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Public Health Preparedness and Response (PHPR) Cooperative Agreement for All-Hazards Public Health Emergencies. According to CDC officials, the Zika supplemental funding awarded through the PHPR cooperative agreement was to enable identified state, territorial, and local jurisdictions to address Zika virus disease planning and operational response gaps. Table 9 presents information for each award as it was provided to us by CDC. Appendix VII: Centers for Disease Control and Prevention—Other Cooperative Agreements’ Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through additional cooperative agreements. Tables 10-17 present information for each award as it was provided to us by CDC. Administrative Support for the Zika Supplemental for Sentinel Enhanced Dengue Surveillance System Project The Zika supplemental funding awarded through the Sentinel Enhanced Dengue Surveillance System Project cooperative agreement was to support sites working to provide new information on dengue and other acute febrile illnesses in Puerto Rico, which is located in the subtropics and where dengue epidemiology is similar to dengue endemic areas worldwide. The Zika supplemental funding was for two studies: (1) pregnant women with Zika infection, and (2) postnatal Zika infection by following 0-5 year old children. Vector-Borne Disease Regional Centers of Excellence The Zika supplemental funding awarded through the Vector-Borne Disease Regional Centers of Excellence cooperative agreement is to establish regional centers of excellence aimed at building the capacity to address the problem of emerging and exotic vector-borne diseases in the United States, including Zika virus infection. Enhancing Capacity for Vector Surveillance and Control to Prevent Zika, Dengue and Chikungunya Infection in Puerto Rico The Zika supplemental funding awarded through the Enhancing Capacity for Vector Surveillance and Control to Prevent Zika, Dengue and Chikungunya Infection in Puerto Rico cooperative agreement is to fund activities to increase the surveillance and control of vectors, specifically Aedes aegypti mosquitoes (the vector of dengue, chikungunya, and Zika). The purpose of the program is to establish a vector control unit to oversee and implement comprehensive vector control activities in Puerto Rico. Immunization Grants-CDC Partnership: Strengthening Public Health Laboratories The Zika supplemental funding awarded through the Immunization Grants-CDC Partnership: Strengthening Public Health Laboratories cooperative agreement is to promote quality and safe public health laboratory practice, improve public health laboratory infrastructure, strengthen the public health laboratory system, and develop a well-trained public health laboratory workforce. Building Capacity of the Public Health System to Improve Population Health through National, Nonprofit Organizations According to CDC officials, the Zika supplemental funding awarded through the Building Capacity of the Public Health System to Improve Population Health through National, Nonprofit Organizations cooperative agreement is to ensure national capacity for responding to the Zika outbreak and meeting the needs of those affected, such as by reaching out to specialized constituents to ensure they were informed on epidemiology and practice guidelines. Strengthening the Public Health System in the U.S.- Affiliated Pacific Islands The Zika supplemental funding awarded through the Strengthening the Public Health System in the U.S.-Affiliated Pacific Islands cooperative agreement is to provide capacity building assistance through a regional, nonprofit organization to strengthen the U.S.-Affiliated Pacific Islands’ public health leadership, workforce, and public health systems and infrastructure in response to Zika virus within the U.S. Pacific territories. Pan American Health Organization: Building Capacity and Networks to Address Emerging Infectious Diseases in the Americas The Zika supplemental funding awarded through the Pan American Health Organization: Building Capacity and Networks to Address Emerging Infectious Diseases in the Americas cooperative agreement is for various activities including technical assistance, such as to develop standard operating procedures for diagnostic and integrated surveillance activities, as well as to support the development, implementation, and evaluation of diagnostic and surveillance guidelines. Global Health Security Partner Engagement: Expanding Efforts and Strategies to Protect and Improve Public Health Globally According to CDC officials, the Zika supplemental funding awarded through the Global Health Security Partner Engagement: Expanding Efforts and Strategies to Protect and Improve Public Health Globally cooperative agreement is for enhanced surveillance for pregnant women in Colombia, including laboratory testing and case investigations. Appendix VIII: Centers for Disease Control and Prevention—Contracts and Interagency Agreements This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through additional contracts and interagency agreements. Tables 18 and 19 present information for each award as it was provided to us by CDC, as well as the activity funded. Appendix IX: Centers for Medicare & Medicaid Services—Zika Health Care Services Program Awards This appendix presents information on Zika supplemental funding awards made by the Centers for Medicare & Medicaid Services (CMS) through the Zika Health Care Services Program. The Zika Health Care Services Program is aimed at supporting prevention activities and treatment services for women (including pregnant women), children, and men adversely or potentially affected by the Zika virus. According to CMS documentation, the Zika Health Care Service Program is intended to address four critical components of a comprehensive response to Zika: 1. Increase access to contraceptive services for women and men. 2. Increase access to and reduce barriers to diagnostic testing, screening, and counseling for pregnant women and newborns. 3. Increase access to appropriate specialized health care services for pregnant women, children born to mothers with maternal Zika virus infection, and their families. 4. Improve provider capacity and capability. CMS awarded funding through the Zika Health Care Services Program, in two award rounds, to states, territories, tribes, or tribal organizations with active or local transmission of the Zika virus, as confirmed by the Centers for Disease Control and Prevention. In January 2017, CMS awarded funding to American Samoa, Florida, Puerto Rico, and the U.S. Virgin Islands. In June 2017, CMS awarded funding to Texas, the only new area with local transmission of the Zika virus. Table 20 presents the awards CMS made through its Zika Health Care Services Program. Appendix X: Health Resources and Services Administration’s Zika Supplemental Awards This appendix presents information on Zika supplemental funding awards made by the Health Resources and Services Administration (HRSA) to health centers and for Special Projects of Regional and National Significance. Health centers: HRSA provided awards to health centers through supplemental grant awards to support existing health centers in Puerto Rico and other territories in their efforts to expand the delivery of health care services, including the prevention of Zika and prevention and treatment of Zika-related illness. HRSA also provided supplemental grant awards to existing Health Center Program cooperative agreement awardees for efforts to provide training and technical assistance for Zika-related health center expansion activities. Special Projects of Regional and National Significance: HRSA provided awards for Special Projects of Regional and National Significance to support public health departments and other entities in Puerto Rico and other territories in efforts to ensure access to recommended services for pregnant women, infants, and children infected by the Zika virus in the prenatal, perinatal, and neonatal period. Activities include early identification through developmental screening, regular assessments and monitoring, telemedicine, care coordination, enabling services, family engagement and family-to- family support; purchasing of diagnostic equipment and health information technology; and the training of health care providers, care coordinators, and other health care and public health professionals to ensure delivery of comprehensive, interdisciplinary health and social services for this population. Tables 21 and 22 present information for each award as it was provided to us by HRSA. Appendix XI: National Institutes of Health Zika Supplemental Awards The National Institutes of Health (NIH) awarded Zika supplemental funding to support research to better understand Zika and its complications, and inform the development of new interventions. The three primary activities of funding include (1) vaccine development; (2) Zika in Infants and Pregnancy study; and (3) diagnostics, therapeutics, vector control, and other interventions. NIH used contracts, grants, intramural research awards, and other awards to provide funding for research on the Zika virus and its complications. Tables 23-26 present information for each award as it was provided to us by NIH. Appendix XII: GAO Contact and Staff Acknowledgments GAO Contact Staff Acknowledgments In addition to the contact named above, Karen Doran (Assistant Director), Sarah Resavy (Analyst-in-Charge), and Hannah Grow made key contributions to this report. Also contributing were Muriel Brown, Christine Davis, and Drew Long.
target: Zika—a virus primarily transmitted through mosquito bites—can cause symptoms that include fever, rash, and joint and muscle pain. In pregnant women, the Zika virus can be passed to the fetus and cause severe brain defects. In response to an outbreak in the United States and its territories, Congress appropriated $932 million in September 2016 through the Zika Response and Preparedness Act to HHS and its agencies to prevent, prepare for, and respond to the Zika virus and its related health conditions, and conduct related research. The act also included a provision that GAO study the activities supported with the appropriated funds. This report describes (1) the status of funds obligated and disbursed from the Zika supplemental funding appropriated to HHS and its agencies; and (2) how selected awardees used their Zika supplemental funding, and their experiences with applying for and managing the funding. To do this work, GAO reviewed agency documents on Zika supplemental funding and activities, and interviewed officials from the HHS agencies and selected awardees. To select awardees, GAO identified states based on the amount of initial Zika supplemental funding they received from CDC, the Centers for Medicare & Medicaid Services, and the Health Resources and Services Administration; and selected states with the highest and lowest funding. In total, GAO selected 12 awardees: 10 states, as well as one county and one city from 2 of the 10 states. GAO provided a draft of this report to HHS. In response, HHS provided technical comments, which were incorporated as appropriate. As of September 30, 2017, Department of Health and Human Services’ (HHS) agencies had obligated nearly all of the $932 million of Zika supplemental funding Congress appropriated in 2016 through the use of multiple funding mechanisms, including cooperative agreements, grants, and contracts. Four HHS agencies had small unobligated balances as of the September 30, 2017, obligation deadline; these balances cannot be used to incur new obligations, but may be used to adjust award amounts in future years. Disbursement of the obligated funds was ongoing, with about 21 percent of the Zika supplemental funding (approximately $195.5 million) disbursed as of December 31, 2017. The agencies have until September 30, 2022, to disburse the remainder. The 12 awardees GAO interviewed—officials from 10 states and two local entities—funded multiple activities with their Zika supplemental funding, and had varying experiences applying for and managing the funds. Awardees told GAO that they used their funding to support such activities as collection of information about individuals affected by the Zika virus (human surveillance), mosquito control activities, laboratory capacity building, public outreach, and health care services. For example, Florida used Zika supplemental funding in its state-run laboratories to purchase materials for testing Zika virus-related specimens. A majority of the awardees GAO spoke with reported positive experiences applying for and managing the Zika supplemental funding, including good communication with agency officials and awardees’ familiarity with the mechanisms used to make the awards. However, some awardees noted challenges, such as time frames to use the funding that varied among multiple awards and identifying the activities that could be funded. These challenges added administrative burdens to applying for and managing the Zika supplemental funding while officials were responding to the outbreak, according to the awardees. In October 2017, the Centers for Disease Control and Prevention (CDC) issued a new notice of funding opportunity that agency officials said is intended to help minimize the administrative burden on states and certain localities during emergencies—such as preparing applications—by pre-approving public health departments in these jurisdictions to be eligible to rapidly receive future awards.